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| March 13, 2008 |
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"The simple truth as I see it today is that the FDA of the 20th century is not adequate to regulate the food and drugs of the 21st century... FDA was created one hundred years ago because change had created peril along with promise, and today FDA must be re-created because the peril and promise from these products is now even greater... It is no secret in Washington that as the FDA’s responsibilities have grown; the resources devoted to them have not kept pace. Strengthening the FDA for this new century will require an investment, providing our agency with a budget and authorities that are commensurate with the scale and scope of our mission." — FDA Commissioner of Food and Drugs Andrew C. Von Eschenbach, MD, in a speech before the National Press Club in Washington, D.C., on February 29. For the complete speech, click here.
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Separate Diabetes Trial Finds No Evidence of Safety Risk
In contrast with recent news from the ACCORD trial, findings from ADVANCE, the largest ever clinical trial of diabetes treatments, show no evidence that intensive treatment to lower blood glucose is associated with increased mortality....Read More
Alliance Opens Public Comment Period for Clinical Trials Policy Recommendations
A national alliance of scientists, public health leaders, and community representatives in March called for public comment on a series of proposals designed to eliminate continued disparities in U.S. clinical trials....Read More
Hormone Replacement Therapy Not Linked to Rheumatoid Arthritis
A new study using data from the Women’s Health Initiative clinical trials on hormone replacement therapy found that there were no significant differences in the risk of developing rheumatoid arthritis or the severity of the condition between postmenopausal women who were on hormone replacement therapy and those who took placebos....Read More
Study of Targeted Therapies for Breast Cancer Could be Model for Global Clinical Trials
Two targeted medications designed to treat an aggressive form of breast cancer are being tested in a new study involving 8,000 participants in 50 countries across six continents—a clinical trial that investigators hope will provide a new model for global cancer research....Read More
Investigator Attendance at Review Board Reviews: Hindrance or Help?
Inviting researchers to attend institutional review board sessions designed to approve these same investigators’ requests to conduct research involving human subjects does not seem to affect the efficiency of the process one way or the other, a new study led by Johns Hopkins bioethicists suggests....Read More
Sensor Necklace Aims to Increase Drug Compliance
Researchers have designed a sensor necklace that records the date and time a pill is swallowed, which they hope will increase drug compliance, decrease unnecessary healthcare costs, and help subjects in clinical drug trials take the study medications as directed by the research team....Read More
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In the News: A roundup of major media coverage of issues impacting the conduct of and public perceptions about clinical research (6 news items added since the last issue of the Wire)
Clinical Trial Updates: Announcements from corporations, institutions, and journals about findings from recent trials, treated in brief (10 new updates added since the last issue of the Wire)
Campus Connections: An overview of the latest developments in clinical research at academic centers (5 new announcements added since the last issue of the Wire)
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The April 2008 issue of The Monitor, featuring 12 peer reviewed articles on the theme of "International Harmonization," is already available online for ACRP members who log in here.
ACRP and APPI have launched a campaign to support a federal effort to honor patient participants in clinical trials. The effort is embodied in House Resolution 248, which encourages public recognition of clinical trial participants, and we need your help. For more information, click here.
The ACRP Forum Roadmaps, your guide to which sessions and workshops at the upcoming ACRP 2008 Global Conference & Exhibition most closely fit your areas of expertise and interest, are available in a downloadable PDF here.
Research organizations and funders should combine efforts to produce an open-source solution for trial data management, say two researchers in an essay in the March issue of the free online journal PLoS Medicine, "Could an Open-Source Clinical Trial Data-Management System Be What We Have All Been Looking For?"
The Pharmaceutical Research and Manufacturers of America delivered a new report this month that highlights how America's pharmaceutical research companies are testing 547 new medicines to help treat neurological diseases.
Northwestern University's 2008 Clinical Research Educational Conference and Poster Session will be held on May 16 in Chicago. ACRP members are invited to register online here at a discounted rate. The event is sponsored by Northwestern University's Feinberg School of Medicine and NUCATS Institute in collaboration with ACRP.
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© 2007-2008 Association of Clinical Research Professionals. All rights reserved.
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